Clinical Trials Directory

Trials / Completed

CompletedNCT06757400

Τhe Effect of Lumbar Spine Mobilization and Manipulation on Pressure Pain Threshold in Patients With NSLBP

Τhe Effect of Lumbar Spine Mobilization and Manipulation on Pressure Pain Threshold in Patients With Non-specific Chronic Low Back Pain: a Cross-over Randomised Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
27 (actual)
Sponsor
University of West Attica · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

Summary

Manual therapy, including mobilizations and manipulations, appears to be as effective as other types of therapy for chronic low back pain. The aim of this cross-sectional study is to compare the effects of lumbar spine mobilization and manipulation on the pressure pain threshold in patients with non-specific chronic low back pain.

Detailed description

Background: Manual therapy, including mobilizations and manipulations, appears to be equally effective as other types of therapy for chronic low back pain. According to the Orthopaedic Section of the American Physical Therapy Association (APTA), there is evidence indicating that these techniques can reduce pain, improve spinal and hip mobility, and decrease disability in patients with low back pain. The aim of this study is to compare the effects of lumbar spine mobilization and manipulation on the pressure pain threshold in patients with non-specific chronic low back pain. Methods: The present study will be a cross-sectional study in which participants will be men and women aged 18 to 60 years. The sample size was estimated by effect size, with a minimum of 27 participants required to provide statistically or clinically significant results. Each subject will receive two interventions-mobilization or manipulation-on two different days, in a random order. The primary outcomes will be pain perception, including subjective pain intensity and pressure pain threshold. Secondary outcomes will include the range of motion (ROM) of lumbar spine flexion, extension, and lateral flexion. Data will be collected before and after each intervention. Assessors will use a digital algometer, an electronic inclinometer, and a numerical rating scale (NRS). ANOVA and t-test calculations will be performed on data processed by SPSS Version 25 to analyze results for all outcomes. The level of significance will be set at 5% (p = 0.05) with a confidence interval of 95% (CI = 95%).

Conditions

Interventions

TypeNameDescription
OTHERMobilizationMobilization will be conducted on an examination table with the subject in prone position. Therapist will place his hypothenar to the most hypomobile lumbar spine segment after assessment.It will be a posteroanterior (PA) direction tecnique, Maitland's GRADE 4, 3 sets of 60 seconds duration for each set.
OTHERmanipulationManipulation will be conducted on an examination table with the subject in right lateral decubitus. It will be a rotary manipulation to the most hypomobile lumbar spine segment after assessment.

Timeline

Start date
2023-11-04
Primary completion
2024-02-28
Completion
2024-04-23
First posted
2025-01-03
Last updated
2025-01-06

Locations

1 site across 1 country: Greece

Source: ClinicalTrials.gov record NCT06757400. Inclusion in this directory is not an endorsement.